Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

NCT ID: NCT00599430

Last Updated: 2008-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-05-31

Brief Summary

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The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Inert excipient

Active 1

One probiotic strain

Group Type ACTIVE_COMPARATOR

Lactobacillus acidophilus NCFM

Intervention Type DIETARY_SUPPLEMENT

1e10 CFU/day

Active 2

Blend of two strains

Group Type ACTIVE_COMPARATOR

Combination of Lactobacillus acidophilus and Bifidobacterium lactis

Intervention Type DIETARY_SUPPLEMENT

1x10e10 CFU/day

Interventions

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Placebo

Inert excipient

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus acidophilus NCFM

1e10 CFU/day

Intervention Type DIETARY_SUPPLEMENT

Combination of Lactobacillus acidophilus and Bifidobacterium lactis

1x10e10 CFU/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Children aged 3-5 years of normal nutritional status and health

Exclusion Criteria

* Contraindications to dairy products (lactose intolerance or cow's milk allergy)
* Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
* Chronic cough from recurring respiratory distress-related diseases
* Hirschsprung's disease
* Cystic fibrosis
* Other metabolic, neurological, or anatomic alteration that predisposes participation
* Intake of probiotics within the last 3 weeks
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Danisco

Principal Investigators

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Charlie Zhang

Role: STUDY_DIRECTOR

Sprim Advanced Life Sciences

Cheryl Riefer

Role: STUDY_CHAIR

Sprim Advanced Life Sciences

Locations

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Day care center

Jinhua, Zhejiang, China

Site Status

Countries

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China

References

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Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27.

Reference Type DERIVED
PMID: 19651563 (View on PubMed)

Other Identifiers

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06-02-D-011

Identifier Type: -

Identifier Source: secondary_id

Danisco - Mao

Identifier Type: -

Identifier Source: org_study_id

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